Barrett Esophagus
Conditions
Keywords
Endosign® Cell Collection Device, Barretts Esophagus
Brief summary
This study is looking at cells collected from the esophagus using a diagnostic device called the EndoSign® Cell Collection Device (a sponge on a thread). Subjects swallow a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread. These cells will be tested to check for a condition called "Barrett's Esophagus." The cells from the sponge will be tested using Cyted Health biomarkers and compared to the results from a regular endoscopy and any biopsies that are taken. To do this, we need sponge samples from people who might have Barrett's Esophagus based on their risk factors, and from people with Barrett's Esophagus. Subjects will have one visit to have the Endosign Cell Collection Device administered prior to having a standard of care endoscopy. They will answer some questions about their medical history and experience with the cell collection procedure as part of the study. Data will be collected from medical records including post-endoscopy.
Interventions
DEVICEBarrett's Esophagus Test (LDT)
Barrett's Esophagus Test (LDT) will be performed on esophageal cells collected using the EndoSign Cell Collection Device (510(k) cleared) and compared to the results of standard of care EGD plus biopsies (if applicable)
Sponsors
Cyted Health Inc
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
High Risk Screening: Closed November 2025 Barrett's Esophagus Inclusion Criteria * Undergoing a standard of care EGD (with or without endoscopic eradication therapy {EET}) * Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD/EET or day of EGD/EET). * Willing and able to sign informed consent * Confirmed Barrett's Esophagus of length at least 1 cm or greater. This includes non-dysplastic Barrett's, low-grade dysplasia, high-grade dysplasia or adenocarcinoma.
Exclusion criteria
* Previous EGD result was indefinite for dysplasia * Previous endoscopic eradication therapy (EET) * Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm dia.)) * Known or suspected gastric or esophageal varices * Known or suspected portal hypertension * Taking anti-thrombotic medications that cannot be discontinued * Taking GLP-1 agonists that cannot be discontinued for 1 week prior to sponge administration * Previous gastric or esophageal surgery (including Nissen fundoplication) * History of oropharyngeal tumor * History of myocardial infarction or cerebrovascular accident in past 6 months * Known or suspected to be pregnant (self-report for woman of child-bearing potential)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of Barrett's Esophagus Test (LDT) compared to standard of care. | Sample collection prior to standard of care endoscopy | Performance of the biomarker for detecting BE or confirming no BE in the study population. Sensitivity and specificity are co-primary endpoints. Samples are collected using the EndoSign Cell collection device, tested in a CLIA lab and compared to endoscopy/pathology diagnosis confirmed by independent central pathology review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess subject self-reported experience with the EndoSign Cell Collection Device | At the Baseline Visit | Use of a 10-point scale to assess subject's experience with the device where 0 is no issues and 10 is the worst experience on a number of device-specific questions |
| Proportion of Subjects meeting Sample Assay Requirements | At study completion, about 1.5 years | Proportion of subjects among those with cell samples obtained and sent to the central laboratory for processing with DNA yield as well as QC pass of the sequencing process by applying thresholds specified in the laboratory's CLIA/CAP documentation. |
| Performance of BE Test by Prague, Histopathology grade and Seattle Protocol Adherence. | Sample collection prior to standard of care endoscopy | Sensitivity by histopathological grade: NDBE, all BE with neoplasia or EAC, and separately for indefinite for dysplasia (IND), low grade dysplasia (LGD), high grade dysplasia (HGD) / intramucosal carcinoma (IMC), and EAC. Sensitivity by length of BE segment. Short-segment BE is defined as \<3 cm in length . Long-segment BE is defined as 3 cm or longer. Sensitivity and specificity of the Barrett's Esophagus Test in the subgroup entering via the HRS pathway. Sensitivity and Specificity based on adherence to the Seattle biopsy Protocol Lack of adherence to the Seattle biopsy protocol (defined as either: 1) \<1 specimen jar per 2 cm of BE and/or 2) lack of documentation of adhering to the biopsy protocol) is common and may impact detection of true positive BE patients. Sensitivity and specificity will be dichotomized by Seattle protocol status, and false positive cases will be compared to true positives for adherence to the protocol. |
Countries
United States
Contacts
CONTACTMelissa Tuck, M.S.
CONTACTKeith Fiman, M.D.
PRINCIPAL_INVESTIGATORCo-Lead Investigator
University of North Carolina
Outcome results
None listed